On April 15th the Supreme Court will begin hearing cases regarding the patenting of parts of human genes. The outcome could change the way many companies – including the Austin-based Genformatic – operate.
Before the human genes were mapped and put into the public domain, many companies took out patents for certain gene sequences. Businesses such as Myriad Genetics have whole segments of patient’s DNA held under proprietary patents, making them unusable to anyone else. This has made it difficult for many companies to provide the best care for their patients.
“It’s as if somebody had a patent on the X-ray images of the pelvic region of a human being,” says Daniel Weaver of Genformatic. “You could administer the test, but you wouldn’t be able to inform the patient about that region. It’s crazy.”
The Supreme Court will determine whether or not genes are patentable property, or whether, since medical science needs the information of genetic sequences, they must be kept entirely public, thereby giving physicians and companies full access to the information so that it can be used to further the cause of healthcare.
Many in the biotechnology industry are worried that gene patenting will make it impossible for researchers to devise workable solutions to many diseases, such as breast and ovarian cancer. Being able to use the gene sequences helps those hunting for determining markers to make valid judgements regarding a patient’s risk for certain diseases and the likely efficacy of many treatments.
Current estimates are that nearly 41% of human DNA has been patented. If the Supreme Court rules that those patents cannot be held, they will be released to the public. The ramifications could be widespread, and the possibility of huge profit losses by the companies holding those patents is very likely.
The legal waters in this area are very murky. Even if the courts determine that the patents must be released, it might not mean that the information will become public. The testing methods used to find those particular gene sequences would still be protected, and since it would be illegal to duplicate them, the DNA markers would still be proprietary information under the protection afforded by the patents of the methods for garnering the genetic information.